PULSE（通过生活方式教育进行预防）试验方案：一项针对男性的2型糖尿病预防计划的随机对照试验。

The PULSE (Prevention Using LifeStyle Education) trial protocol: a randomised controlled trial of a Type 2 Diabetes Prevention programme for men.

作者信息

Aguiar Elroy J, Morgan Philip J, Collins Clare E, Plotnikoff Ronald C, Young Myles D, Callister Robin

机构信息

Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.

Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Education, Faculty of Education and Arts, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia.

出版信息

Contemp Clin Trials. 2014 Sep;39(1):132-44. doi: 10.1016/j.cct.2014.07.008. Epub 2014 Aug 1.

DOI:10.1016/j.cct.2014.07.008

PMID:25092484

Abstract

BACKGROUND

Intensive lifestyle interventions have been successful in reducing type 2 diabetes incidence. Whether intensive programmes requiring face-to-face contact, trained staff and access to facilities are feasible, on a larger scale, has been debated.

OBJECTIVES

The aim of this study is to determine the feasibility and efficacy of a lifestyle intervention for type 2 diabetes prevention in men using an assessor-blinded, parallel-group, randomised controlled trial. The 'Type 2 Diabetes PULSE (Prevention Using LifeStyle Education) Programme for Men' is a 6-month, self-administered, gender-tailored lifestyle intervention, with a multicomponent approach (weight loss, dietary modification, aerobic exercise and resistance training). Eligible men were aged 18-65 years, overweight/obese (BMI 25-40 kg·m(-2)) and at high-risk for type 2 diabetes (score ≥ 12, Australian diabetes risk tool). Men with diagnosed prediabetes were eligible, but those with type 1 and 2 diabetes were ineligible. Randomisation was stratified by age (<50 or ≥ 50 years) and BMI category (kg·m(-2): 25-29.9; 30-34.9; 35-40) to the intervention or wait-list control group. Data are collected at study entry (baseline), 3 and 6 months. The primary outcome is weight change at 6 months. Secondary outcomes include: fasting plasma glucose, HbA1C, waist circumference, body composition, blood pressure, diet quality, aerobic fitness, muscular fitness and physical activity. Generalised linear mixed models (intention-to-treat) will assess outcomes for treatment (intervention vs. control), time (baseline, 3 and 6-months) and the treatment-by-time interaction.

CONCLUSION

The results will determine the efficacy of a type 2 diabetes prevention programme for men with potential for wide reach and dissemination.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry (ACTRN12612000721808).

摘要

背景

强化生活方式干预已成功降低2型糖尿病发病率。需要面对面接触、训练有素的工作人员和使用设施的强化项目在更大规模上是否可行，一直存在争议。

目的

本研究旨在通过一项评估者盲法、平行组、随机对照试验，确定针对男性预防2型糖尿病的生活方式干预的可行性和效果。“男性2型糖尿病PULSE（通过生活方式教育预防）项目”是一项为期6个月的自我管理、针对性别的生活方式干预，采用多组分方法（体重减轻、饮食调整、有氧运动和抗阻训练）。符合条件的男性年龄在18 - 65岁之间，超重/肥胖（体重指数25 - 40 kg·m⁻²）且患2型糖尿病风险高（得分≥12，澳大利亚糖尿病风险工具）。已诊断为糖尿病前期的男性符合条件，但1型和2型糖尿病患者不符合条件。按年龄（<50岁或≥50岁）和体重指数类别（kg·m⁻²：25 - 29.9；30 - 34.9；35 - 40）分层随机分配至干预组或等待名单对照组。在研究入组时（基线）、3个月和6个月收集数据。主要结局是6个月时的体重变化。次要结局包括：空腹血糖、糖化血红蛋白、腰围、身体成分、血压、饮食质量、有氧适能、肌肉适能和身体活动。广义线性混合模型（意向性分析）将评估治疗（干预与对照）、时间（基线、3个月和6个月）以及治疗与时间交互作用的结局。